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Human trials to develop an ultra-rapid COVID-19 breath test to start in Delhi

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Through the capture of unique breath biomarkers, the hand-held disposable digital test, reportedly uses next-generation nanosensors and cloud-based artificial intelligence to analyse the sample for biomarkers of the virus, in less than 3 minutes; could be on the global market by Q1 2021

US-based Canary Health Technologies (Canary) and DIVOC Laboratories (Divoc), a Delhi-based laboratory certified by the National Accreditation Board for Testing and Calibration Laboratories (NABL), will collaborate on a trial to develop an ultra-rapid and highly accurate breath test for the detection of COVID-19.

As per a release, through the capture of unique breath biomarkers, the disposable digital test, which mitigates contamination, uses next-generation nanosensors and cloud-based artificial intelligence for analysis.

The hand-held digital test which requires minimal training can be performed at the point of care without the need of a lab. Canary’s cutting-edge R&D and manufacturing facility based in Bangalore is at the center of this technological development.

Using exhaled Volatile Organic Compounds (VOCs) found in human breath as biomarkers of the virus, this screening test (ASU Detect CV19) is designed to detect the virus in people with and without symptoms. US CDC recently noted that most of the COVID spread is caused by people without any symptoms. While current tests measure the viral load in a person to determine if they are infected, Canary’s breath test aims to detect the person’s metabolic response nearly immediately after infection.

Viral infections increase oxidative stress. The highly reactive free radicals produced by oxidative stress are powerful biomarkers of the diseases found in exhaled breath. The presence of unique VOC signatures in COVID-19 and similar viruses like rhinovirus, influenza, MERS and SARS are well established. Designed to detect a COVID-19 infected person in less than three minutes, the disposable breath test, which mitigates the risk of contamination, reportedly uses highly sensitive nanosensors to collect breath samples and cloud-based pattern recognition technology to determine if a person is infected.

The companies plan to conduct a clinical trial of 750 subjects in Delhi to yield preliminary results before the end of December, and will aim to be in the market early 2021. It is reportedly the first and largest clinical trial using a real-time breath test for the detection of an infectious disease with cloud-based artificial intelligence for pattern recognition as the analytical tool.

It will be carried out according to international Good Clinical Practice (GCP) standards. The trial is being conducted under registration with the Clinical Trials Registry- India (CTRI) and the trial protocol was approved by the ethics committee of the Good Society Ethical Research. Trials in the US and Europe are also being planned and are due to start before the end of 2020.

ASU Detect CV19 is developed on Canary’s breath analysis platform which is also being developed to diagnose cancer, infectious diseases and inflammatory diseases. In 2019, a clinical trial in Canada demonstrated that the platform can detect lung cancer with high sensitivity and specificity. Proof of concept and pivotal trials for a number of high-burden diseases are being planned in the US and Asia. A trial to diagnose rheumatoid arthritis is due to start in New York in January, 2021. Canary has also performed bench studies for tuberculosis, with promising results, indicating that a highly sensitive breath test for TB is within reach. Discussions are on-going with global health actors to start a trial for TB detection at the start of 2021.

Not only will ASU Detect CV19 have the ability to detect the disease from the time of infection, because the results are analysed in a cloud-based system, the platform will also reportedly provide real-time surveillance for disease monitoring, and track and trace initiatives. Health authorities will be able to see disease hotspots as they form and respond quickly.  Ultra-rapid screening at airports and other high density and transmission areas will drastically reduce the potential for disease transmission, and allow COVID-free people more freedom of movement.

Professor Ashok Rattan, the Principal Investigator of the trial, a prominent lab scientist who was formerly professor at the All India Institute of Medical Sciences (AIIMS), New Delhi and Lab Director of PAHO / WHO administered Central Asia Regional Economic Cooperation Program, said, “This is next-generation technology and has the ability to completely revolutionise testing for COVID-19 and play a critical role in stopping the spread of the virus. Currently there does not exist an ideal test that could be a real time, non-invasive, highly accurate mass screening tool to be used to reduce transmission. The biomarkers in the breath are as unique as our fingerprints in the identification of diseases. The Canary breath test has the potential to responsibly open the economy and protect the population.”

The trial will see the collection of breath samples from 750 people – both COVID-19 positive patients and those who do not have the virus. They will be asked to breathe into the device. The device will then translate their breath biomarkers into electronic signals which will be transmitted to a centralised “lab in the cloud” for analysis. Preliminary results are expected before the end of December 2020.

If the trial is successful, Canary Health Technologies will seek to move quickly to apply for fast-track regulatory approval while continuing to trial the test in real-world settings such as at airports, in resorts and in other high density areas.

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